Event Calendar

In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes. NAMSA invites you to attend this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval.

Register today for MDMA’s flagship event, the 2022 MDMA Annual Meeting, which will be held, IN PERSON, April 27-29th. Hear from Congressional, Federal Agency and industry leaders and visit Capitol Hill during their popular Congressional Fly-In. *BioOhio Members can save $100! Contact a BioOhio team member for your discount code.

FBI Cincinnati Division in coordination with Butler County Sheriff’s Office Bomb Squad, is holding a Chemical Industry Outreach Workshop (CIOW). Who Should Attend: The focus of this CIOW is to conduct and develop liaisons with chemical industry safety/security professionals, chemical industry health and safety experts, other chemical industry representatives, chemical sales (industrial and retail), and academia. The CIOW is part of the FBI’s National Improvised Explosive Familiarization (NIEF) initiative designed to raise awareness of the use of common chemicals to produce improvised explosives. The classroom portion of this training will be held at Butler Tech. The main body of morning briefings will focus on FBI initiatives, capabilities/investigations and the overall chemical threat. After a networking break, FBI Special Agent Bomb Technician will provide a brief on explosives and associated Improvised Explosive Devices (IED’s). The afternoon will consist of a short field trip to the Butler County Bomb Squad explosives range for a live demonstration of various explosives and IED’s; most of which can be mixed using common household chemicals. Please RSVP by 4/21/2022.

Join JumpStart for the next episode of Founders Unfiltered featuring Afif Ghannoum, co-founder of BIOHM Health. Afif, a biotechnology attorney by training, co-founded BIOHM with his father Dr. Mahmoud Ghannoum, a global leader in medical mycology and Case Western Reserve University Professor. The father and son duo launched BIOHM in 2016 to help bring Dr. Ghannoum’s science to consumers, commercializing probiotics and microbiome testing kits to target fungi and bacteria in the digestive tract. JumpStart will talk to Afif about BIOHM’s recent funding round, the results of their groundbreaking clinical trials and his work commercializing healthcare innovation.

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Health’s legacy of delivering the MedCon Conference.

Innovation: Setting your Company Up for Success in Commercialization, Adoption, and Further Investment. Presented by Project Medtech, this online event features speaker Kipum (Kip) Lee, a designer, scholar, and healthcare executive. Currently, he serves as Vice President of Innovation & Product Strategy at University Hospitals (UH) in Cleveland, OH where he leads a team of innovators within UH Ventures – the innovation and commercialization arm of health system. His day-to-day work involves managing the innovation portfolio and “living lab” that supports University Hospitals’ strategic initiatives and partnerships through product innovation and human-centered design. Earlier in his career, he was part of the team at frog design that produced a mobile service around HIV awareness and self-testing in South Africa that was hailed by The Economist as “the world’s largest field trial in mobile health technology.” He also helped plan and lead the design of Marriott Mobile, which debuted at number four in the iTunes App Store and shortly went on to become the third-largest in mCommerce after Amazon and Apple.

This annual conference brings together leading authorities from FDA, industry and academia to address the latest statistical trends and issues facing medtech organizations. In an effort to provide quality programming in the safest and most effective manner possible, the Conference will once again be held virtually this year. Dates: Wednesday, May 11th – Friday, May 13th

The labor crisis is happening now. Business leaders must take immediate actions to protect and expand their workforce in the short term. Part 1 of the Summit will share the current picture of Ohio’s workforce landscape, and present insights and approaches that every Ohio business can consider implementing today. We will explore organizational change management, incumbent upskilling, candidate recruitment expansion and other critically-immediate business actions that can strengthen business profitability and enhance quality of life for all. • Creating change for the long run. Building a workforce with the resilience to take on the unknown challenges of the future will require transformative, long-term action in the areas of education, economic development, and regional positioning. Together, these investments will drive long-term advantages in transportation, infrastructure, and community prosperity. Part 2 will present the long-term private sector solutions that every Ohio business can help power to reach that goal.

ARM, in partnership with BioOhio and JobsOhio, will hold its first state event in Columbus in May, showcasing Ohio’s leadership in creating a hub for the cell and gene therapy field. The event will include a panel discussion from 4:00 pm – 5:00 pm, followed by a reception from 5:00 pm – 7:00 pm.

Harrington Discovery Institute accelerates promising discoveries into medicines for unmet needs focusing on Major Diseases, Brain Health Medicines, COVID-19, and Rare Diseases. Our work endeavors to improve human health and better our world. We are driven by passion, innovation, and integrity, to cure diseases together.